Cleared Traditional

URIC ACID (LIQUID) REAGENT SET (K970560) - FDA 510(k) Clearance

Class I Chemistry device.

K970560 · Pointe Scientific, Inc., · Chemistry device
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Mar 1997
Decision
26d
Days
Class 1
Risk

K970560 is an FDA 510(k) clearance for the URIC ACID (LIQUID) REAGENT SET. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on March 11, 1997 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1775 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pointe Scientific, Inc., devices

Submission Details

510(k) Number K970560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1997
Decision Date March 11, 1997
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNK Acid, Uric, Uricase (colorimetric)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1775
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KNK Acid, Uric, Uricase (colorimetric)

All 117
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K970560.
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ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34
K913706 · Em Diagnostic Systems, Inc. · Sep 1991
COBAS READY PROFILE 2 REAGENT STRIP
K896225 · Roche Diagnostic Systems, Inc. · Jun 1990